Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intraoperative Visual Index Score
研究概览
简要总结
The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery.
The main questions it aims to answer are:
- Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema?
- Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view?
- Does either bowel preparation method cause more discomfort or side effects before surgery?
Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery.
Participants will:
- Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery.
- Undergo standard laparoscopic surgery for endometrial cancer.
- Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.
详细描述
Adequate bowel preparation is important for achieving optimal surgical exposure during laparoscopic surgery for endometrial cancer. Inadequate bowel preparation may impair visualization of the operative field, requiring steeper Trendelenburg positioning and higher pneumoperitoneum pressures, which may increase the physiological burden of surgery and affect operative performance.
Mechanical bowel preparation with rectal enema is commonly used before gynecologic surgery, although its routine use remains controversial because evidence supporting its clinical benefit is limited. A standardized 3-day bowel preparation protocol may improve patient tolerance while maintaining adequate surgical conditions. However, prospective randomized studies comparing these two approaches specifically in laparoscopic endometrial cancer surgery remain limited.
This prospective randomized controlled trial will compare a standardized 3-day bowel preparation protocol with a preoperative rectal enema before laparoscopic surgery for endometrial cancer. The primary objective is to determine whether the dietary bowel preparation protocol can provide surgical conditions comparable to those achieved with rectal enema.
In addition to subjective assessment of surgical exposure, the study will evaluate objective intraoperative parameters, including the minimum Trendelenburg position and the minimum pneumoperitoneum pressure required to maintain an adequate surgical view. Operative outcomes, postoperative recovery, patient tolerance of the bowel preparation methods, and bowel preparation-related symptoms will also be evaluated.
The findings of this study may help optimize preoperative bowel preparation strategies, reduce unnecessary patient burden, and support evidence-based perioperative care for patients undergoing laparoscopic surgery for endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Because of the nature of the interventions, participants and the study nurse responsible for preoperative bowel preparation cannot be blinded. Operating surgeons assessing the intraoperative primary outcomes will remain unaware of treatment allocation until completion of the intraoperative assessment. Postoperative data collection and statistical analyses will be performed by the study investigators.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 to 90 years.
- •Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
- •Willing and able to provide written informed consent.
排除标准
- •Planned open (abdominal) surgery.
- •Known allergy or contraindication to sodium phosphate rectal enema.
- •Age over 90 years.
- •Refusal or inability to provide written informed consent.
研究组 & 干预措施
Low-Residue Diet
Participants will follow a standardized 3-day bowel preparation protocol before surgery. The protocol includes a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery
干预措施: Low-Residue Diet (Behavioral)
Rectal Enema
Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol
干预措施: Sodium Phosphate Rectal Enema (Drug)
结局指标
主要结局
Intraoperative Visual Index Score
时间窗: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Surgical exposure will be assessed intraoperatively using the Visual Index score after establishment of pneumoperitoneum and placement of the camera trocar and one lateral ancillary trocar. The score ranges from 0 to 2, where 0 indicates inadequate visualization despite bowel retraction with one grasper, 1 indicates adequate visualization requiring bowel retraction with one grasper, and 2 indicates adequate visualization without bowel retraction. Higher scores indicate better surgical exposure.
Minimum Trendelenburg Position Required for Adequate Surgical Exposure
时间窗: Intraoperatively
The minimum Trendelenburg angle (degrees) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure
时间窗: Intraoperatively
The minimum pneumoperitoneum pressure (mmHg) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
次要结局
- Operative Time(During surgery)
- Length of Hospital Stay(At hospital discharge, assessed up to 30 days after surgery)
- Time to First Flatus(From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days)
- Patient Tolerance of Bowel Preparation(From preoperative bowel preparation until postoperative day 1)
研究者
Mahmut Yassa
Gynecologic Oncology Specialist
Başakşehir Çam & Sakura City Hospital